The Alliance for Regenerative Medicine reported in its January 2024 meeting that, up to 17 regulatory approvals in the U.S. and Europe are anticipated for the coming year in cell & gene therapies, compared to eight approvals in 2023. This is despite the impact & changes in priorities caused by COVID-19. In the CGT field, chimeric antigen receptordirected (CAR-T) cell therapies have emerged as a groundbreaking approach for treating patients with cancers that previously had proved to be resistant to available conventional therapies. Specifically, CAR-T cell therapies targeted against antigens expressed on B cells (CD19 and BCMA) have been successful in treating blood-related cancers. Now we are seeing early promising results in expanding CAR-T application to autoimmune diseases, providing new hope for patients suffering from these debilitating conditions.
Evolution and Medications Approved to Date
CAR-T therapy has come a long way since its inception, with significant advancements in design, manufacturing and clinical applications. The first CAR-T therapy approved by the U.S. Food and Drug Administration (FDA) in 2017, Novartis’s Kymriah, targeted CD19-positive B cell malignancies, such as acute lymphoblastic leukemia and non-Hodgkin lymphoma. Since then, five more CAR-T therapies targeting CD19 and BCMA antigens (Tecartus, Abecma, Yescarta, Breyanzi and Carvykti) have been approved. To date, across all six FDA-approved CAR-T therapies, drugmakers have reported treating about 34,400 patients worldwide, and these therapies have demonstrated remarkable efficacy, with durable remissions in patients who have exhausted other treatment options. The success of CAR-T therapy in hematologic diseases has sparked interest in exploring its potential in treating other indications.
This story is from the BioSpectrum Asia May2024 edition of BioSpectrum Asia.
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This story is from the BioSpectrum Asia May2024 edition of BioSpectrum Asia.
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